Efficacy and Safety of FTY720 in De Novo Adult Renal Transplant Recipients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00239902

Purpose

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Condition	Intervention	Phase
Renal Transplantation	Drug: FTY720	Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: FTY 720

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Two-Year Extension of a One-Year, Multicenter, Randomized, Partially-Blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-Dose Cyclosporine, USP [Modified] (Novartis Brand) in De Novo Adult Renal Transplant Recipients

Further study details as provided by Novartis:

Primary Outcome Measures:

IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
Permanent resumption of dialysis within 36 months post transplant
Surgical removal of graft within 36 months post transplant
Death within 36 months post transplant
Discontinuation within 36 months post transplant

Secondary Outcome Measures:

FEV1 , FVC, DLCO within 36 months post transplant
Serum creatinine and estimated creatinine clearance within 36 months post transplant
Absolute lymphocyte count within 36 months post transplant

Estimated Enrollment:	396
Study Start Date:	May 2002

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239902

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	CFTY720A0121E1
Study First Received:	October 13, 2005
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00239902 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Transplantation, kidney, and organ transplantation

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Fingolimod
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Fingolimod
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009